BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 3902629 · Received May 9, 2014

    Report

    Report Number
    2249723-2014-00569
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 25, 2013
    Report Date
    April 26, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SVC REP CONFIRMED THAT THE AUTO FILL FAILURE WAS CAUSED BY A LEAK IN THE SYSTEM. THE IABP WAS REPAIRED AND PUT BACK INTO SVC. THE FOLLOWING PARTS WERE REPLACED: 1 X 0008-00-0312-TUBING BLOOD DETECT; 1 X 0040-00-0147-5000H PM KIT; 2 X 0004-00-0050-HOSE VACUUM; 2 X 0004-00-0051-HOSE PRESSURE; 1 X 0102-00-0001-PUMP ASSEMBLY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, THEY RECEIVED AN "AUTOFILL FAILURE" ALARM. THE PT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282369 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS100

    Patients

    Seq Age Sex Outcome Treatment
    1